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U.S. Department of Health and Human Services

Class 2 Device Recall Sumitomo Bakelite Co.

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  Class 2 Device Recall Sumitomo Bakelite Co. see related information
Date Initiated by Firm September 09, 2016
Create Date November 10, 2016
Recall Status1 Terminated 3 on November 10, 2016
Recall Number Z-0389-2017
Recall Event ID 75388
510(K)Number K152771  
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
Product SB (Sumitomo Bakelite Co.,) Electrosurgical Knife
Size: Working Length 1.8M Maximum OD 2.6mm.


Product Usage:
The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
Code Information Lot No.: 60564713
Recalling Firm/
Manufacturer		 Akita Sumitomo Bakelite Co., Ltd.
27-4, Aza Nakajimita
Akita Japan
Manufacturer Reason
for Recall		 Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
FDA Determined
Cause 2		 Error in labeling
Action Sumitomo Bakelite on September 9, 2016 initiated removal of all SB Knife from US accounts. The information was emailed to the accounts and Sumitomo Bakelite requested all customers not to use the mislabeled SB Knife and return product for replacement.
Quantity in Commerce 8 units
Distribution US in the states of MA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNS and Original Applicant = SUMITOMO BAKELITE CO., LTD.
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